Target Animal Safety Scientist

Target Animal Safety Scientist

Role Description

Zoetis Veterinary Medicine Research and Development (VMRD) is looking for a highly motivated and skilled veterinary scientist to join the Target Animal Safety Group within the Clinical Pharmacology and Safety Sciences (CPSS) group based in Kalamazoo, MI. This challenging and dynamic role includes combining clinical and scientific expertise to develop scientifically rigorous target animal safety strategies that are critical to supporting regulatory approvals and ensuring the safe, effective use of Zoetis products globally. The candidate will collaborate across VMRD on a range of projects from early discovery research through full product development and post-approval support for both small and large molecules, across therapeutic areas and across species, including livestock.

Responsibilities:

• Serve as the Technical Lead and Subject Matter Expert on cross-functional project teams to define and implement the safety strategy and studies as required for project stage and progression. Includes providing input into budget forecasting, project milestone planning, and other safety-related risk assessments.
• Propose and gain concurrence on safety strategies; interpret and communicate data to project teams, management, and regulators; and identify multi-disciplinary solutions to recommend a course of action guiding complex projects. Includes collaboration with other key cross-functional partners such as PK/PD, clinical development, biomarkers, clinical pharmacology, and regulatory.
• Critically evaluate and apply toxicology and immunology literature to support safety assessments, study design and regulatory strategy, providing expert input to project teams.
• Author and review safety study protocols to be conducted by VMRD staff or by our contract research organization (CRO) partners, monitor safety studies conducted at CROs, and may serve as a GLP study director for safety studies conducted in Zoetis facilities.
• Remain current with global regulatory requirements relating to target animal safety (e.g . VICH, FDA-CVM, EMA-CVMP, USDA-CVB, and other regional regulatory agencies), and apply this knowledge to safety strategy, study design, and regulatory submissions in collaboration with VMRD Regulatory Affairs
• Author and review technical sections for regulatory submissions in support of product approval and defense worldwide. Contribute to product labeling, product defense, and pharmacovigilance-related support as needed.
• Author manuscripts and/or position papers for publication in the scientific literature.
• Support regulatory compliance and represent Zoetis in trade associations and professional organizations relevant to animal health, to stay informed, align with industry standards, and contribute to shaping regulatory policy.
• Occasional travel (<15%) to CROs and regulatory bodies as required to support drug development plans and studies conducted to support the drug safety of veterinary products is required, with additional opportunities to travel for internal and external meetings.
• This position will be hired as a hybrid position, with on-site presence at Zoetis VMRD headquarters in Kalamazoo, Michigan required ≥50% of the time.

Minimum skills, education, experience, attributes:

• DVM (or equivalent) plus at least 5 years of experience in a related animal health field
• Strong understanding of pharmacology, toxicology and/or immunology, with ability to translate how basic biology may inform clinical findings from safety studies
• Demonstrated skills in regulatory-quality technical writing (protocols, reports, expert statements, dossiers, journal articles etc.) as well as oral communication skills in scientific venues are required.
• Highly organized with strong problem-solving skills, capable of performing rigorous scientific assessments.
• Ability to prioritize tasks, make informed decisions, and work effectively and collaboratively in a global matrix environment.
• Proficiency in MS Office, and databases for literature research and data analysis

Desirable skills, education, experience, attributes:

• PhD and/or Board Certification in a veterinary specialty is desirable
• Veterinary clinical practice experience is highly desired
• Knowledge and experience with livestock species
• Knowledge and experience with biopharmaceutical drug development
• Experience in the design, implementation, and interpretation of GLP-complaint safety studies  including experience as a GLP Study Director is desired

Location: Kalamazoo, Michigan (hybrid). You must live locally and be able to commute to the lab. Work arrangement is approximately. 50% onsite, 50% f